【国外标准】 Standard Practice for Evaluating Efficacy of Vaporous Decontaminants on Materials Contaminated with Bacillus Spores and Contained Within 0.2µm Filter-Capped Tubes

5.1 The practice can be used to evaluate coupon materials of any composition, insofar as the coupon can be prepared small enough to fit inside a 50-ml conical tube.5.2 This practice defines procedures that are quantitative, scalable, rapid, sensitive, safe, reduces consumables, minimizes labor and addresses statistical confidence (1, 2, 4).5.2.1 Quantitative—The total number of spores per coupon is determined by dilution-plating, and all spores remaining on the coupon are assayed for activity in the extraction tube to provide confidence that 100 % of spores were assayed.5.2.2 Statistical Confidence—The use of five independent preparations of spore inoculum for a statistical N of 5.5.2.3 Sensitivity—Allows for complete detection of all viable spores inoculated on a coupon, including the spores that remain attached to the coupon.5.2.4 Safety—Inoculated coupons are contained within 0.2 µm filter-capped 50-ml conical tubes. The 0.2 µm filter allows vaporous decontaminants to pass through while preventing escape of spores, thereby providing an important level of containment when working with pathogenic strains.5.2.5 Simplicity of Testing—Tests and extractions are performed in the same 50-ml conical tube to minimize handling steps.5.2.6 Scalable and Rapid—A maximum of 36 samples can be processed in 1 h by two technicians; a total of 300 samples have been processed by six technicians in 5 h (1-3).5.2.7 Wide application for numerous Bacillus species and strains.NOTE 1: This practice differs from similar quantitative methods (E2111, E2197 and E2414) in the size and variety of coupon materials available for testing, in the practical confidence of the statistics, the application of the decontaminant, scalability and sensitivity.1.1 This practice is used to quantify the efficacy of vaporous decontaminants on Bacillus spores dried on the surface of coupons made from porous and non-porous materials and contained within 0.2µm filter-capped tubes.1.2 This practice should be performed only by those trained in microbiological techniques, are familiar with antimicrobial (sporicidal) agents and with the end use of such products.1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.